MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOTOME REVOLVE STEREOTACTIC PROBE; BIOPSY SYSTEM

Model Number MST0812

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

The mammotome revolve dual vacuum assisted biopsy system is intended to obtain tissue samples from the breast or axillary nodes for diagnostic analysis of breast abnormalities.Affiliate reports that before procedure the technician hurt herself with an 8g probe while using it to calibrate the mammograph.She cut her finger and received medical attention and received 3 stitches.Our ifu was reviewed and confirmed that there are several precautions listed regarding the probe.Some examples include: keep hands clear of the sample aperture and probe needle tip at all times.The protective sleeve should remain on the probe needle until you are ready to perform the tissue sampling procedure.Based on the details of how the event occurred and information provided in the ifu it was determined that this event did not occur as a result of a device malfunction.Review of the complaint database did not identify any similar events.

Event Description

Affiliate reports that before procedure the technician hurt herself with an 8g probe while using it to calibrate the mammograph.She cut her finger and received medical attention and received 3 stitches.

Manufacturer Narrative

The initial report was submitted on 09-feb-2023.The purpose of this follow up report is to correct g6 in the initial report which should have the "initial" box checked.D4 serial & lot number sections were corrected.The number was removed from serial number section and added to the lot number section.E1 address was corrected.

• Brand Name: MAMMOTOME REVOLVE STEREOTACTIC PROBE
• Type of Device: BIOPSY SYSTEM
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; parque industrial, tijuana 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way fifth floor; cincinnati, OH 45241
• MDR Report Key: 16342670
• MDR Text Key: 309259829
• Report Number: 3008492462-2023-00003
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K152989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MST0812
• Device Lot Number: F12245431D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Hispanic